FDA device listing

Latitude EV,MaxLock

FDA device listing 1025812550 · STRYKER CORP.

Key facts

Proprietary names Latitude EV,MaxLock
Owner/operator STRYKER CORP.
Owner/operator number 1811755
Product codes HXP
Device names HXP - Instrument, Bending Or Contouring
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments TORNIER Inc., TORNIER, INC.
Establishment registrations 1649390, 3004983210
FEI numbers 3000718467, 3004983210
Establishment operations Complaint File Establishment, Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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